Regulatory Affairs Professionals
You are dedicated to communication of complex scientific matters in a written form and have experience with global regulatory CMC requirements for biological products and Regulatory Life Cycle Management of medicinal products globally. If you also enjoy cross-functional interactions, then you might be our new colleague in one of the two open positions within the Regulatory CMC department of Global Regulatory Affairs. The department counts 25 employees organised in three teams, hereof two in Hørsholm, Denmark. The two positions are placed in the Tablets & Next Generation team and the Injectables, Drops and Devices team, respectively. Both positions are in Hørsholm, Denmark
Fields of responsibility
- Responsible for writing and maintaining regulatory CMC documentation for initial and life cycle submissions.
- Responsible for having an overview of submitted and approved CMC documentation in different regions.
- Cross-functional and external cooperation related to product development and/or strategic expansion.
- Regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions.
- Establishment of the right strategy for CMC documentation and submission.
- Provide regulatory guidance for various cross-functional areas.
- Monitor global regulatory requirements related to CMC.
- A Master of Science, e.g. in pharmacy, engineering or other relevant discipline.
- Thrive on scientific discussions with the goal of clarifying needs and identifying solutions.
- Experience with regulatory CMC requirements.
- Open towards other departments and external stakeholders.
- Enjoy preparing clear and logically organised written material on complex scientific matters.
- Excellent communication skills, written and orally.
- Value teamwork and prefer meeting challenges as a team.
- Result oriented and able to keep the perspective in times of increased activity.
The following qualifications will be an advantage:
- Experience with CMC development in the pharmaceutical industry.
- Experience with global regulatory CMC requirements for biological products.
- An exciting and challenging job with your own areas of responsibilities.
- Good opportunities for personal as well as professional development.
- A dynamic work environment with highly motivated colleagues and a strong team spirit.
In Global Regulatory Affairs, we provide an attractive working environment for Regulatory Affairs Professionals looking for both personal and professional development. ALK is a global pharmaceutical company in progress offering unique job opportunities. You will be part of a dynamic and dedicated team who continuously strive to improve.
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Scion science park in Hørsholm.
For further information please contact Managers Dorte Friis Christensen (+45 2145 3919) or Pernille Elgaard Høj (+45 5089 9585).
How to apply
Please click on "Apply here" and kindly remember to attach a letter of motivation and CV. We are looking forward to hearing from you.
Application deadline: 1 November 2016.
ALK is a global research-driven pharmaceutical company focusing on allergy prevention, diagnosis and treatment. We are the world’s leading company within allergy immunotherapy. We are constantly moving forward as we have maintained our pioneering spirit. We are large enough to offer you both challenges and good opportunities for development, but not large enough for you to disappear in the crowd.
We have experienced success and significant growth in recent years, and together with our international partners we work to expand the use of allergy immunotherapy worldwide. Therefore we need employees who both desire and are capable of influencing the company.